Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety

Xenon Pharmaceuticals • Needham, MA

29d • Hybrid

About The Position

We are seeking a Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety to join our team. The Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety will be accountable for setting the medical safety strategy for the assigned Company’s product in early or late state development and/or post approval. They will be responsible for defining the product’s safety risks, safety risk mitigation strategies and safety risks language for inclusion in clinical development and regulatory documents. They will be also accountable for the benefit-risk assessment of the assigned Company’s product throughout the product lifecycle (from First-In-Human to post-marketing), safety surveillance during clinical development and post-approval, and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management of the assigned Company’s product. The successful candidate will lead a cross-functional Safety Risk Management Team (SRMT), and collaborate closely with colleagues in Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affairs, Medical Affairs, non-clinical safety lead, QA and Legal departments amongst others.
This position reports to the Vice President, Drug Safety and Pharmacovigilance, Medical Safety, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Requirements

• Medical degree (MD) required, with at least 5 years’ experience in clinical/medical practice preferred.
• Minimum of 7 years’ experience as a safety physician in drug safety & pharmacovigilance for products in clinical trial and post-marketing environments.
• Experience authoring and overseeing safety signal assessment report, DSUR, PBRER, RMP/REMS, and RSI.
• Experience in all phases of global drug development process from pre-IND through NDA and post-licensure, clinical development and NDA submissions.
• Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations.
• Experience with Argus or ARISg systems, Global Safety Database data mining and MedDRA coding.
• Excellent interpersonal communication and presentation skills
• Time management skills with ability to prioritize meeting required deadlines.
• Ability to multitask and work under tight deadlines while prioritizing attention to important details and high-quality work in a dynamic environment.
• Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment.

Nice To Haves

• Neuropsychiatry experience is desirable

Responsibilities

• Lead the global Medical Safety strategy for assigned company’s product including development and maintenance of the overall safety product profile of the product including safety risk register, risk mitigation, safety risk communication and safety review and surveillance strategies throughout the product lifecycle from First-In-Human to post-marketing.
• Ensure timely delivery of safety contributions, in accordance with DSPV processes, to support clinical development strategies and plans throughout the product lifecycle from First-In-Human to post-marketing.
• Lead cross functional safety surveillance activities as a product GSL and chair of the SRMT. Key contributor to the review of safety data from all sources and escalate potential safety signals to safety governance when warranted as per governance SOP and work instructions (WI).
• Develop a strong working relationship and alignment with the three other pillars of pharmacovigilance: Risk Management and Safety Governance, Safety Surveillance and Aggregate Reports, and Pharmacovigilance Operations, Compliance and Systems.
• Develop a strong working relationship with cross-functional colleagues, and in particular close working relationship with Clinical Development physicians and Regulatory Affairs leads, and as needed with Biostatistics and Programming, Data Management, Medical Affairs, Non-Clinical Safety lead, Quality Assurance and Legal departments amongst others.
• Foster a culture that promotes a shared company-wide responsibility for “Patient Safety First” by: Applying an initiative-taking approach to manage medical safety risks through communication with pears and when needed escalation to senior leadership.
• Ensuring adherence to regulatory safety compliance and company’s development strategy.
• Responsible for contributing medical safety expertise to safety surveillance, signal detection, risk management, benefit-risk assessment and periodic safety update reports throughout the product lifecycle from First-In-Human to post-marketing.
• Ensure that safety data from non-clinical studies are reviewed and considered when creating and updating safety risk register and risk mitigation strategies in study protocols (e.g. dose escalation).
• Support NDA submission and or ad hoc documents and communications to Regulatory Agencies for assigned Company’s product throughout the product lifecycle from First-In-Human to post-marketing.
• The role supports the Head of Medical Safety in ensuring that all safety related activities comply with applicable local and global regulatory standards and pharmacovigilance exchange agreements with corporate partners
• Activities include timely submission of all safety reports to worldwide health authorities and in compliance with applicable with worldwide regulatory safety reporting requirements and industry-standard best practice.
• Ensure careful and timely review of safety concerns escalated by internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment for assigned Company’s product.
• Provide guidance and ensure that safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), and IB Reference Safety Information (RSI) are aligned with the most current Company’s product specific Safety Risk Language.
• Provide guidance for safety sections of clinical study documents including Statistical Analysis Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, Manuscripts, and other relevant documents.
• Responsible for medical review of ICSRs in Company’s Global Safety Database including but not limited to case narrative, MedDRA coding, labeling, causality, company comment and queries for the assigned Company’s product.
• Responsible for the medical safety input for the development of Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authorities’ requests for safety information.
• Identify key medical safety issues, trends, and early risk identification for assigned Company’s product and proactively develop and recommend effective mitigation strategies.
• Collaborate with Clinical Development and Medical Affairs to develop publications and clinical data communications; review scientific publications such as posters, abstracts, and manuscripts.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
• Some international travel may be required
• Other duties as assigned

Benefits

• Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
• Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown.
• Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree